NCT00639002 · ADVERSE EVENTS

Adverse events

A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma · Source last updated 2018-02-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Baseline to end of study
Other-event reporting threshold: 5%

Safety population: All subjects who were enrolled and took at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ruxolitinib Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.	6 / 13	11 / 13	Not reported / Not reported
Ruxolitinib + Dexamethasone Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.	6 / 7	6 / 7	Not reported / Not reported

Group identifiers: EG000: Ruxolitinib · EG001: Ruxolitinib + Dexamethasone

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pneumococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Overdose

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Hilar lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Bundle branch block left
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Conjunctival haemorrhage

Complete source fields

description

Safety population: All subjects who were enrolled and took at least 1 dose of study medication.

event Groups

description
Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
id
EG000
other Num Affected
11
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Ruxolitinib
description
Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
id
EG001
other Num Affected
6
other Num At Risk
7
serious Num Affected
6
serious Num At Risk
7
title
Ruxolitinib + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Hilar lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Bundle branch block left
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Conjunctival haemorrhage

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
2
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
group Id
EG001
num Affected
0
num At Risk
7
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Pneumococcal sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
13
group Id
EG001
num Affected
1
num At Risk
7
term
Overdose

time Frame

Baseline to end of study

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Preserved source evidence · Not medical advice